Modern Western medicines typically consist of a single, purified chemical entity administered to a patient to mediate a specific biochemical pathway. In contrast, many non-Western medicinal compounds that are used by many traditional cultures around the globe are often comprised of several botanicals and botanical extracts. Based on a pharmacognosy with several long-standing pharmacopeias effective in treating a wide range of diseases and their symptoms, these traditional compositions typically include a multiplicity of minimally-processed, naturally occurring ingredients. Composed without the benefit of modern clinical and scientific theory and knowledge, these traditional compositions were often derived from empiric observations in humans over the millennia. Yet, nevertheless, they often contain several biologically active, phytochemical components that act simultaneously and synergistically on multiple molecular targets and cellular mechanisms.
In recent decades in the United States, the active compounds in botanicals and phytochemicals derived from plant extracts have become an area of interest for treating diseases and their symptoms by both healthcare professionals and patients alike. There are many documented examples of this in contemporary scientific, clinical and lay literatures, and in the USPTO patent archive. These is also interest in compositions that combine one or more botanical extracts with one or more other medicinal compounds, pharmaceuticals or other synthetic chemical entities. Some of these compositions are intended to potentiate or modify specific therapeutic effects. In the United States, many of these medicinal compositions are widely used and are commercially available as over-the-counter dietary supplements that do not require a physician's prescription. In some cases, such compounds are available only with a physician's prescription.
The National Institutes of Health (NIH) estimate three out of five U.S. consumers take dietary supplements or nutritional products on a regular daily basis to maintain good health. This is due in large part to demographics, as aging Baby Boomers strive to stay healthy based on the belief that proper nutritional supplementation can avert, or in some instances even replace, the need for costlier prescription drugs and treatments, especially if one has a chronic disease condition. For example, the American Diabetes Foundation, reports that patients with diabetes are 1.6 times more likely than patients without diabetes to use complementary medicinal products such as herbal treatments, nutritional products and medical foods. The Foundation estimates that 17-30% of all diabetics routinely use health care supplements and/or alternatives to prescription pharmaceutical use. Some of these are used to improve blood glucose control; others to manage various symptoms or lessen the risk of developing serious, later-stage diabetic complications.
An example of a dietary supplement aimed at combating pain and inflammation in joints and connective tissue is Bioinflammatory Plus™, a product which includes White Willow Bark in a powder supplement, and Turmeric root in a capsule formulation. These formulations combine a number of ingredients; however, they do not show combining specific botanicals to achieve beneficial effects in addressing recurring peripheral neuropathy or retinopathy.
The USPTO has granted patents for complex herbal compositions and novel formulations used to treat various human and animal diseases and their associated symptoms. These include novel compounds that have been extracted from natural botanical sources and/or synthesized chemically; in some cases the novel compounds are complex combinatorial compositions of several botanicals in combination with synthetic chemical ingredients. These herbal compositions and formulations have targeted a variety of acute and chronic diseases and symptoms, including specific diseases such as various types of cancer, diabetes and arthritis. These herbal compositions and formulations also target various types of symptoms clinically associated with various diseases, as well as symptoms from down-stream sequelae, side effects and adverse events causally related to physician administered or prescribed medications. Examples of patents issued by the USPTO for botanical compositions and formulations used for the treatment include both acute and chronic diseases range from viral infections to cancer, diabetes and arthritis and various symptoms associated a disease include but are not limited to (each of which are herein incorporated by reference): treating glioblastomas with a complex herbal composition that includes modulating gene expression (U.S. Pat. No. 7,931,922); a herbal composition and method for combating inflammation (U.S. Pat. No. 6,541,045); the treatment of ocular inflammation with a composition containing the plant-based alkaloid, tetrandrine (U.S. Pat. No. 5,627,195); a complex composition of multiple botanical ingredients targeting inflammation and related symptoms (U.S. Pat. No. 5,683,697); a composition comprising a mixture of herbs, including species of Scutellaria barbata, as well as their extracts, which is used to ameliorate the effects of malignancy in humans (U.S. Pat. No. 5,437,866); and a formulation of various herbal ingredients which include Glycyrrhiza glabra L. and Scutellaria baicalensis Georgi, Rabdosia rubescens, and Serenoa repens for the treatment of prostate carcinoma (U.S. Pat. No. 5,665,393).